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    Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial (NCT05554380)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    09/22/2023
    Primary completion :
    08/31/2025
    Completion :
    08/31/2025
    AKT2
    |
    AKT1 mutation
    |
    paclitaxel • ipatasertib (RG7440)
    Testing ONC201 to Prevent Colorectal Cancer (NCT05630794)
    Phase 1
    National Cancer Institute (NCI)
    Not yet recruiting
    Last update posted :
    02/21/2025
    Initiation :
    03/30/2025
    Primary completion :
    01/01/2026
    Completion :
    01/01/2028
    BCL2 • IL6 • TNFA • IL10 • CASP3 • GZMA • IL17A • PRL
    |
    dordaviprone (ONC201)
    Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers (NRG-GY028) (NCT05538897)
    Phase 1/2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    03/31/2023
    Primary completion :
    01/31/2027
    Completion :
    01/31/2027
    AKT1S1
    |
    ipatasertib (RG7440) • megestrol
    Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia (NCT05881265)
    Phase 2
    Shanghai Jiao Tong University School of Medicine
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    05/15/2023
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    RARA • PML
    |
    Venclexta (venetoclax) • Epidaza (chidamide)
    Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer (NRG-GY027) (NCT05276973)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/07/2025
    Initiation :
    09/08/2022
    Primary completion :
    01/30/2025
    Completion :
    01/30/2025
    PTEN • HRD • NF1 • AKT1 • TSC1 • AKT1S1
    |
    HRD
    |
    carboplatin • paclitaxel • ipatasertib (RG7440)
    Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (NCI-2021-13902) (NCT05172258)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/07/2025
    Initiation :
    07/26/2022
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    PD-L1
    |
    Keytruda (pembrolizumab) • ipatasertib (RG7440) • Pembroria (pembrolizumab biosimilar)
    Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ... (NCT02390752)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/03/2025
    Initiation :
    04/29/2015
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    NF1
    |
    Turalio (pexidartinib)
    Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma (NCT05958719)
    Phase 2
    Institute of Hematology & Blood Diseases Hospit...
    Recruiting
    Last update posted :
    12/30/2024
    Initiation :
    03/02/2023
    Primary completion :
    12/30/2026
    Completion :
    03/02/2027
    IFNG • IL6 • TNFA • IL10 • IFNA1
    |
    azacitidine • prednisone • Epidaza (chidamide) • Duoenda (mitoxantrone liposomal)
    Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia (NCT06532552)
    Phase 2
    The First Affiliated Hospital of Soochow Univer...
    Recruiting
    Last update posted :
    11/20/2024
    Initiation :
    07/29/2024
    Primary completion :
    08/01/2027
    Completion :
    08/01/2028
    BCL2
    |
    Venclexta (venetoclax) • azacitidine • Epidaza (chidamide) • cladribine
    Mechanism Investigation of R-CHOP Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2/MYC Protein Double Expressor Lymphoma (DEL Biomarker) (NCT06652152)
    Phase N/A
    Ruijin Hospital
    Not yet recruiting
    Last update posted :
    10/22/2024
    Initiation :
    10/30/2024
    Primary completion :
    05/30/2025
    Completion :
    12/30/2025
    BCL2
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • Epidaza (chidamide)
    Trial of Olaparib in Combination with AZD5363 (ComPAKT) (NCT02338622)
    Phase 1
    Royal Marsden NHS Foundation Trust
    Completed
    Last update posted :
    09/26/2024
    Initiation :
    03/31/2014
    Primary completion :
    03/21/2016
    Completion :
    03/21/2017
    BRCA1 • BRCA2 • PARP1
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Lynparza (olaparib) • Truqap (capivasertib)
    Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant. (NCT06563778)
    Phase 2
    Chinese PLA General Hospital
    Not yet recruiting
    Last update posted :
    08/21/2024
    Initiation :
    09/01/2024
    Primary completion :
    09/01/2026
    Completion :
    09/01/2028
    PD-1
    |
    decitabine • Adcetris (brentuximab vedotin) • Epidaza (chidamide) • bendamustine
    Systemic Therapy and Chemoradiation in Advanced Localised Pancreatic Cancer - 2 (SCALOP-2) (NCT02024009)
    Phase 1/2
    University of Oxford
    Completed
    Last update posted :
    07/25/2024
    Initiation :
    03/01/2016
    Primary completion :
    06/23/2021
    Completion :
    06/23/2021
    KRAS
    |
    gemcitabine • capecitabine • albumin-bound paclitaxel • Viracept (nelfinavir)
    Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma (NCT04674683)
    Phase 3
    HUYABIO International, LLC.
    Active, not recruiting
    Last update posted :
    06/24/2024
    Initiation :
    08/12/2021
    Primary completion :
    12/01/2024
    Completion :
    10/01/2025
    BRAF
    |
    PD-L1 expression • BRAF mutation • PD-L1 negative
    |
    Opdivo (nivolumab) • Epidaza (chidamide)
    Combination Therapy for the Treatment of Diffuse Midline Gliomas (NCT05009992)
    Phase 2
    University of California, San Francisco
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    10/20/2021
    Primary completion :
    12/31/2025
    Completion :
    06/30/2029
    BRAF
    |
    dordaviprone (ONC201) • paxalisib (GDC-0084)
    Chidamide+Decitabine Plus Anti-PD-1 Antibody in PD-1 Inhibitor Failed Patients With Classical Hodgkin Lymphoma. (NCT06393361)
    Phase 2
    Chinese PLA General Hospital
    Recruiting
    Last update posted :
    06/11/2024
    Initiation :
    06/01/2024
    Primary completion :
    06/01/2026
    Completion :
    06/01/2027
    PD-1
    |
    carboplatin • gemcitabine • ifosfamide • etoposide IV • decitabine • pegylated liposomal doxorubicin • Adcetris (brentuximab vedotin) • Epidaza (chidamide)
    Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC (NCT05720260)
    Phase 2
    National Taiwan University Hospital
    Recruiting
    Last update posted :
    06/10/2024
    Initiation :
    01/17/2023
    Primary completion :
    12/31/2024
    Completion :
    01/31/2027
    ER
    |
    ER positive
    |
    Imfinzi (durvalumab) • fulvestrant • Truqap (capivasertib) • goserelin acetate
    Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer (IPATential150) (NCT03072238)
    Phase 3
    Hoffmann-La Roche
    Completed
    Last update posted :
    06/07/2024
    Initiation :
    06/30/2017
    Primary completion :
    03/16/2020
    Completion :
    04/24/2024
    PTEN
    |
    PTEN loss
    |
    abiraterone acetate • ipatasertib (RG7440) • prednisone • prednisolone
    A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (MORPHEUS) (NCT03280563)
    Phase 1/2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    06/06/2024
    Initiation :
    12/26/2017
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    HER-2 • PD-L1
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • tamoxifen • Verzenio (abemaciclib) • fulvestrant • ipatasertib (RG7440) • exemestane • Jingzhuda (entinostat)
    Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) (NCT04862663)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    06/06/2024
    Initiation :
    05/10/2021
    Primary completion :
    11/01/2027
    Completion :
    08/14/2029
    HER-2 • ER • PGR
    |
    HER-2 negative • PGR expression
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Truqap (capivasertib)
    A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer (NCT04586270)
    Phase 1
    Taiho Oncology, Inc.
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    10/15/2020
    Primary completion :
    08/01/2024
    Completion :
    07/01/2027
    HER-2 • KRAS • PTEN • NF1
    |
    KRAS mutation • HR positive • KRAS G12C • HER-2 negative • KRAS G12D • NF1 mutation • KRAS G12 • HR positive + HER-2 negative
    |
    TAS0612
    A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (SNARE) (NCT05593497)
    Phase 2
    VA Office of Research and Development
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    05/31/2024
    Primary completion :
    05/01/2027
    Completion :
    08/01/2027
    PTEN
    |
    abiraterone acetate • Truqap (capivasertib) • leuprolide acetate for depot suspension
    Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Women With a PI3K Alteration and HR+/Her2- Breast Cancer (Amelia-1) (NCT05455619)
    Phase 1/2
    SynDevRx, Inc.
    Recruiting
    Last update posted :
    05/22/2024
    Initiation :
    08/26/2022
    Primary completion :
    03/01/2026
    Completion :
    09/01/2026
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • evexomostat (SDX-7320)
    mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian (NCT02208375)
    Phase 1/2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/11/2014
    Primary completion :
    12/30/2025
    Completion :
    12/30/2025
    ER • PGR • BRCA • MUC16
    |
    BRCA mutation
    |
    Lynparza (olaparib) • Truqap (capivasertib) • vistusertib (AZD2014)
    Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER) (NCT04650581)
    Phase 3
    Canadian Cancer Trials Group
    Active, not recruiting
    Last update posted :
    05/09/2024
    Initiation :
    01/27/2021
    Primary completion :
    06/30/2024
    Completion :
    12/31/2026
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    fulvestrant • ipatasertib (RG7440)
    Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules (NCT01226316)
    Phase 1
    AstraZeneca
    Active, not recruiting
    Last update posted :
    05/09/2024
    Initiation :
    12/01/2010
    Primary completion :
    04/26/2019
    Completion :
    12/31/2024
    HER-2 • ER • PIK3CA • PTEN
    |
    ER positive • PIK3CA mutation • PTEN mutation • AKT1 mutation
    |
    fulvestrant • Truqap (capivasertib)
    Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) (EAY131-Y) (NCT04439123)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/08/2024
    Initiation :
    05/31/2016
    Primary completion :
    11/08/2019
    Completion :
    03/05/2025
    HER-2 • PGR
    |
    HR positive • HER-2 negative
    |
    Truqap (capivasertib)
    GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases (NCT03765983)
    Phase 2
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    05/07/2024
    Initiation :
    02/11/2019
    Primary completion :
    11/30/2024
    Completion :
    11/30/2025
    HER-2 • EIF4EBP1
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • paxalisib (GDC-0084)
    PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma (NCT05083208)
    Phase 1/2
    Henan Cancer Hospital
    Recruiting
    Last update posted :
    05/07/2024
    Initiation :
    02/20/2022
    Primary completion :
    06/30/2024
    Completion :
    01/01/2027
    ALK
    |
    ALK positive • ALK negative
    |
    Epidaza (chidamide) • parsaclisib (INCB50465)
    Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (CAPItello-281) (NCT04493853)
    Phase 3
    AstraZeneca
    Active, not recruiting
    Last update posted :
    04/25/2024
    Initiation :
    07/13/2020
    Primary completion :
    10/04/2024
    Completion :
    03/26/2027
    PTEN
    |
    abiraterone acetate • Truqap (capivasertib)
    A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1 (ENGAGE) (NCT03776071)
    Phase 3
    Denovo Biopharma LLC
    Completed
    Last update posted :
    04/22/2024
    Initiation :
    12/16/2020
    Primary completion :
    02/29/2024
    Completion :
    02/29/2024
    MGMT
    |
    MGMT promoter methylation
    |
    temozolomide • Kinenza (enzastaurin)
    GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases (NCT04192981)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    04/17/2024
    Initiation :
    12/06/2019
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    PIK3CA • PTEN • AKT1 • PIK3R1 • PIK3CG • PIK3CD • PIK3CB • INPP4B • AKT2 • INPP5D • PIK3C3 • PIK3R2 • PIK3R3
    |
    paxalisib (GDC-0084)
    AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC) (NCT03959891)
    Phase 1
    Massachusetts General Hospital
    Active, not recruiting
    Last update posted :
    04/16/2024
    Initiation :
    05/30/2019
    Primary completion :
    12/25/2022
    Completion :
    12/01/2024
    HER-2
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • ipatasertib (RG7440)
    A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma (NCT02975700)
    Phase N/A
    Daiichi Sankyo Co., Ltd.
    Active, not recruiting
    Last update posted :
    04/10/2024
    Initiation :
    01/31/2017
    Primary completion :
    08/31/2018
    Completion :
    03/31/2025
    KIT
    |
    KIT mutation
    |
    Turalio (pexidartinib)
    Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies (NCT01306045)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    04/09/2024
    Initiation :
    02/08/2011
    Primary completion :
    02/12/2014
    Completion :
    12/31/2024
    EGFR • BRAF
    |
    EGFR mutation
    |
    erlotinib • sunitinib • lapatinib • Koselugo (selumetinib) • MK-2206
    A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer (IPATunity170) (NCT04177108)
    Phase 3
    Hoffmann-La Roche
    Completed
    Last update posted :
    03/27/2024
    Initiation :
    11/25/2019
    Primary completion :
    02/28/2023
    Completion :
    02/28/2023
    PD-L1
    |
    Tecentriq (atezolizumab) • paclitaxel • ipatasertib (RG7440)
    Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL) (NCT05008055)
    Phase 2
    AstraZeneca
    Active, not recruiting
    Last update posted :
    03/18/2024
    Initiation :
    11/03/2021
    Primary completion :
    08/22/2023
    Completion :
    06/28/2024
    CCND1
    |
    Chr t(11;14) • CCND1 overexpression • Chr t(11;14)(q13;q32)
    |
    Truqap (capivasertib)
    A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130) (NCT03337724)
    Phase 3
    Hoffmann-La Roche
    Completed
    Last update posted :
    03/12/2024
    Initiation :
    01/06/2018
    Primary completion :
    01/04/2023
    Completion :
    01/04/2023
    HER-2 • PIK3CA • PTEN • AKT1
    |
    HER-2 negative
    |
    paclitaxel • ipatasertib (RG7440)
    Chidamide Bridging for CAR-T Therapy (NCT05370547)
    Phase 1/2
    Chinese PLA General Hospital
    Recruiting
    Last update posted :
    03/06/2024
    Initiation :
    05/25/2022
    Primary completion :
    06/30/2024
    Completion :
    06/30/2025
    BCL2 • BCL6 • PMAIP1
    |
    CD19 positive
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Epidaza (chidamide) • fludarabine IV • Carteyva (relmacabtagene autoleucel)
    Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) (NCT05476939)
    Phase 3
    Gustave Roussy, Cancer Campus, Grand Paris
    Recruiting
    Last update posted :
    03/01/2024
    Initiation :
    09/29/2022
    Primary completion :
    09/01/2028
    Completion :
    09/01/2031
    PTEN
    |
    everolimus • dordaviprone (ONC201)